Search Results

AtriCure's cryolCE cryoSPHERE cryoablation probes are sterile, single use devices intended for use in blocking pain by temporarily ablating peripheral nerves.

The cryolCE cryoSPHERE cryoablation (CRYOS) probe is a single use device that achieves cryoablation of peripheral nerves by allowing a surgeon to insert the probe through an incision to reach the target tissue, place the probe tip on the target site, and in conjunction with an AtriCure Cryo Module (ACM), temporarily freeze the tissue in contact with the probe tip by circulating a cryogenic agent, nitrous oxide, through the device. The CRYOS probe is offered in two probe length configurations: approximately 11" and 18" long. The probe is malleable, and is capable of being bent by the end user. At the distal end, the CRYOS device features an 8 mm diameter ball tip shaped probe.

The provided text describes a 510(k) premarket notification for a medical device, the AtriCure cryoICE cryoSPHERE cryoablation probe. It states that the device is substantially equivalent to a previously cleared predicate device based on bench testing. However, the document does not contain information about the device's performance in a study involving human or animal subjects, nor does it detail acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, accuracy) that would be relevant for an AI/ML-based medical device.

The provided document focuses on demonstrating substantial equivalence for a physical medical device (a cryoablation probe) through non-clinical bench testing. Therefore, it does not provide the information requested in the prompt regarding acceptance criteria and study data for an AI/ML device's diagnostic performance.

Specifically, the document states:

• Performance Data: "The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared CRYO2 device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared CRYO2 device. No new safety or performance issues were raising during testing."
• Non-clinical Bench Testing:
  • Reliability Testing
  • Transit
  • Shelf-life
  • Cryogen Performance/Thermal Insulation
  • Mechanical testing
  • Biocompatibility

Given this, I cannot construct a table of acceptance criteria and reported device performance for an AI/ML diagnostic device, nor can I provide details about sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the information provided in this 510(k) summary for a physical cryoablation probe.

Ask a specific question about this device

AtriCure's cryolCE cryo-ablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.

The cryosurgical handpieces, or cryo-ablation probes, utilized in the AtriCure Cryosurgical System are hand held, single use, cryosurgical instruments intended for the cryosurgical treatment of cardiac arrhythmias during cardiac surgery. The cryosurgical handpieces utilize a high-pressure cryogen (nitrous oxide, N2O) to freeze target tissues, creating an inflammatory response, and ultimately, cryonecrosis. The cryosurgical handpieces provide probe temperatures below -40°C, the temperature at which intracellular ice formation occurs which is considered lethal to cells. When high pressure nitrous oxide is supplied to the cryoprobes via the AtriCure Cryo Module, rapid cooling is achieved via the Joule-Thompson effect. The end effector, or cryotip, of the probes are malleable to allow access to varying anatomy and anatomical sites.

The cryo-ablation probes are comprised of a cryotip end effector, shaft, handle, thermocouple, inlet tube, and exhaust tube. The cryotip consists of an aluminum boiler or stainless-steel boiler and three internal inlet orifices distributed throughout the cryotip internally to provide uniform cooling. The 4-mm diameter, cryotip is malleable throughout its 10-cm length. A supplied forming tool can be used the cryotip into the desired form. The cryotip is attached to an insulated rigid shaft that allows the surgeon to adjust the length of the exposed cryotip up to 10 cm in therapeutic length. A thermocouple is affixed to the proximal external surface of the shaft to display real time temperatures on the console. The handle is attached to the shaft. Inlet and exhaust tubes and thermocouple wire pass through the handle and connect to the AtriCure Cryo Module (ACM).

The provided text is a 510(k) premarket notification from the FDA, describing a medical device called the AtriCure cryoICE cryo-ablation probe. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove a device meets specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable to this type of regulatory submission. This submission is about a modified device and primarily relies on non-clinical bench testing to show that the modifications do not alter the device's performance, safety, or intended use compared to the predicates.

Here's a breakdown of what can be extracted and what information is missing/not applicable based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific quantitative acceptance criteria (e.g., minimum temperature achieved, specific ablation zone size) or their corresponding reported performance values from a clinical study. Instead, it relies on demonstrating equivalence through non-clinical bench testing for specific attributes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in terms of clinical cases or individual patient data. The "test set" here refers to the number of devices or components subjected to non-clinical bench testing. The document states "Non-clinical Bench Testing" was conducted but doesn't specify the sample size for these tests.
• Data Provenance: Not explicitly stated as retrospective/prospective or country of origin for clinical data, because this submission is based on non-clinical bench testing of the device itself, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This submission does not involve human expert interpretation of clinical data to establish ground truth. The "ground truth" for this device's performance is based on direct physical measurements and engineering specifications verified through bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This relates to clinical data adjudication by multiple readers, which is not part of this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a medical device (cryo-ablation probe), not an AI-assisted diagnostic tool. Therefore, MRMC studies and human reader improvement with AI assistance are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This refers to AI algorithm performance. This is a physical medical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• The "ground truth" for this device's performance is based on engineering specifications, direct physical measurements (e.g., temperature, mechanical integrity), and functional testing to ensure it meets its design requirements and operates comparably to the predicate devices. It relies on the inherent physical properties and verified performance during non-clinical bench testing.

8. The sample size for the training set

• Not applicable. This refers to AI model training data. This is a physical medical device.

9. How the ground truth for the training set was established

• Not applicable. This refers to AI model training data. This is a physical medical device.

Summary of the K180137 Submission's Approach:

This 510(k) submission (K180137) is a "Special 510(k)" because it deals with minor modifications to an already cleared device. The core argument for clearance is substantial equivalence to predicate devices. This is established by demonstrating that the modifications (non-patient contacting tube-sets, packaging) do not affect the device's fundamental operating principle, performance specifications, patient-contacting materials, or intended use.

The study that proves the device meets the (implied) acceptance criteria is Non-clinical Bench Testing. The document states that these tests:

• "Demonstrated equivalency in performance" for Mechanical Reliability, Transit, Shelf-life, and Cryogen Performance/Thermal Insulation.
• "Did not raise any new issues of safety."

This type of submission typically avoids extensive new clinical trials if the modifications are minor and substantial equivalence can be demonstrated through rigorous non-clinical testing.

Ask a specific question about this device

AtriCure's cryoICE cryoFORM cryoablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.

AtriCure's cryolCE cryoFORM cryoablation probe (CRYOF) is a sterile, single use, cryosurgical device to be used in coniunction with the AtriCure Crvo Module [K111042. K11207. K140058, K142203) to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The probe is comprised of a cryotip end effector, shaft, handle, thermocouple, inlet tube, and exhaust tube.

The provided text describes the AtriCure® cryoICE™ cryoFORM cryoablation probe (CRYOF) and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study information:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: The "Thigh Prep Study Testing" used an unspecified number of "live porcine thigh tissue models." The text does not provide a specific number of animals or lesions, but it implies multiple lesions were created and assessed for statistical equivalence.
   • Data Provenance: The data is from a prospective GLP (Good Laboratory Practice) animal study conducted on porcine (swine) models. The country of origin of the data is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The text states, "Lesions were assessed using histopathology and morphometric measurements." It does not specify the number or qualifications of experts (e.g., pathologists, veterinarians) who performed these assessments.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • The text does not describe any adjudication method for establishing ground truth from multiple readers/assessors. It simply mentions that lesions were "assessed."

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. The device in question is a cryoablation probe (a surgical tool), not an AI diagnostic or assistance system. The study focused on the physical performance of the device in tissue ablation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a physical surgical instrument and does not involve an algorithm for standalone performance in the context of what is typically considered "standalone AI performance." The performance reported is that of the physical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth for evaluating lesion success was primarily established through histopathology and morphometric measurements of the ablated tissue in a porcine model. This falls under a form of pathological assessment.

7. The sample size for the training set:

   • Not applicable. This submission describes a physical medical device (cryoablation probe) and its performance through animal and bench testing, not an AI/machine learning algorithm requiring a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set for an AI algorithm, this question is irrelevant to the provided document.

Ask a specific question about this device